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    Summary
    EudraCT Number:2009-014597-17
    Sponsor's Protocol Code Number:A4091035
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2009-014597-17
    A.3Full title of the trial
    A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)
    A.4.1Sponsor's protocol code numberA4091035
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTanezumab
    D.3.2Product code PF-04383119
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTanezumab
    D.3.9.1CAS number 880266-57-9
    D.3.9.2Current sponsor codePF-04383119
    D.3.9.3Other descriptive nameRN624, RI624
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTanezumab
    D.3.2Product code PF-04383119
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTanezumab
    D.3.9.1CAS number 880266-57-9
    D.3.9.2Current sponsor codePF-04383119
    D.3.9.3Other descriptive nameRN624, RI624
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTanezumab
    D.3.2Product code PF-04383119
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTanezumab
    D.3.9.1CAS number 880266-57-9
    D.3.9.2Current sponsor codePF-04383119
    D.3.9.3Other descriptive nameRN624, RI624
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic pain including the pain of interstitial cystitis/painful bladder syndrome.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10008927
    E.1.2Term Chronic interstitial cystitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the dose response for tanezumab when administered by SC injection at an 8-weekly interval (2 injections) for moderate to severe chronic pain associated with (IC/PBS).

    To evaluate the safety and tolerability of tanezumab in the treatment of moderate to severe chronic pain associated with IC/PBS.
    E.2.2Secondary objectives of the trial
    To explore the response of IC/PBS urinary endpoints (eg, micturition frequency etc) to tanezumab compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screen Visit 1
    1. Patients must consent in writing to participate in the study by signing and dating an Informed Consent Document indicating that they have been informed of all pertinent aspects of the study prior to completing any of the Screening procedures.
    2. Has an appropriate score on the Painful Bladder/Interstitial Cystitis Symptom Score (PBIC-SS), as outlined in the scoring guidance.
    3. Male and female outpatients aged ≥18 years.
    4. Female patients must meet one of the following criteria:
    a. Female patients of non-childbearing potential: post-menopausal, defined as women who are ≥45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels); amenorrhea for at least 1 year AND have a serum Follicle-Stimulating Hormone (FSH) level greater than 30 IU/L at Screening; or surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy;
    b. Female patients of child-bearing potential: must not be pregnant or lactating and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method).
    Women of childbearing potential must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing.
    Male patients must agree that they and their female spouses/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
    Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of Screening procedures until 16 weeks after the last dose of study medication.
    In the event of indeterminate or anomalous results on pregnancy/FSH testing or issues surrounding contraceptive requirements, study management should be contacted and will make the final decision as to the adequacy/need for contraception.
    5. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, the self-completion of study questionnaires, electronic diary (eDiary), and other trial procedures.
    6. Evidence of cystoscopy within 2 years of Screening to confirm the absence of significant lower urinary tract pathology, and the presence or absence of cystoscopic features of IC/PBS (eg, glomerulations, Hunner’s lesion).
    Note: Cystoscopy is mandated within 2 years of Screening. Patients who have not had cystoscopy within 2 years of Screening must undergo the procedure at Screening.
    Visit 2, Randomization.
    The following continuation criteria have to be met in order for patients to be randomized:
    7. Completes at least 4 average pain scores within any of the 7 days prior to randomization, with a mean average pain intensity score of ≥4 (0-10 NRS); the mean average pain intensity score at Baseline is defined as the mean of all 24-hour average pain intensity scores recorded in the 7 days before Visit 2 (Randomization).
    8. Mean micturition frequency ≥ 8 per 24 hours over any 3 consecutive days in the previous 7 days prior to Visit 2 (Randomization).
    9. Women of childbearing potential must have a negative urine pregnancy test at Visit 2 (Randomization) prior to initial dosing.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
    2. Patients with symptoms of IC/PBS for less than 6 months prior to Screening.
    3. Patients with a post-void residual (PVR) volume >200 mL at Screening (Visit 1).
    4. Patients with a mean voided volume <40 and >400 mL per micturition as measured over 1 day of the 7-day eDiary period completed prior to Visit 2 (Randomization).
    5. Patients with a total daily volume voided of >3500 mL, as confirmed by the eDiary completed prior to Visit 2 (Randomization).
    6. Patients with greater than 1+ hematuria on dipstick test at Screening, unless fully investigated prior to randomization to rule out significant urological disease.
    • Patients who are menstruating may be re-screened once menstruation has ceased if they have been found to have hematuria on dipstick testing.
    7. Patients with a microbiologically-proven urinary tract infection at Screening (Visit 1) or Randomization (Visit 2). Patients can be treated and re-screened.
    8. Patients with the following medical history and comorbid conditions at Screening [see protocol for table].
    9. Patients who have undergone the following procedures [see protocol for table].
    10. Patients with any of the following conditions at Screening:
    • Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC).
    • Passive urinary incontinence (e.g. vesicovaginal fistula).
    • Not capable of independent voiding.
    11. Patients at Screening (Visit 1) who intend to start bladder training program, electrostimulation/neuromodulation therapy (eg, Transcutaneous Electrical Nerve Stimulation (TENS)), acupuncture, or physiotherapy regimen during the study.
    • Patients who are on an established regimen for at least 3 months prior to Screening may remain on this as long as it remains unchanged for the duration of the study.
    12. Taking other treatments for interstitial cystitis at Screening as listed below [see protocol for table].
    Patients are prohibited from taking those medications until Week 24, or Early Termination.
    Note: Patients may remain on ongoing oral medications as background therapy for the treatment of their interstitial cystitis symptoms, provided that they have been administered at a stable dose for at least 3 months prior to Screening and for the duration of the study.
    13. Patients who have participated in a previous tanezumab clinical study.
    14. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
    15. Previous exposure to exogenous NGF or to an anti NGF antibody.
    16. History of intolerance or hypersensitivity to acetaminophen (paracetamol) or any of its excipients, or existence of a medical condition or concomitant medication for which the use of acetaminophen is contraindicated (refer to product labeling).
    17. Patients with a relevant neurological disease at Screening with which their urinary symptoms may be associated (eg, multiple sclerosis, Parkinson’s disease, spinal cord injury, spinal cord lesion, familial neuropathy, spina bifida or diabetic cystopathy); history, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to:
    • Alzheimer’s disease or other types of dementia.
    • Clinically significant head trauma within the past year
    • Peripheral neuropathy
    • Epilepsy or seizure
    • Myopathy
    18. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder, including but not limited to:
    • Psychotic disorders
    • Somatoform disorders
    • Bipolar disorders
    • Any other psychiatric illness that in the opinion of the Investigator would render a patient unsuitable to participate in the study.
    19. Hospital admission for depression or suicide attempt within 5 years of Screening or active, severe major depression at Screening (determined from medical history; if needed, severity of depression may be assessed using the Patient Health Questionnaire [PHQ-9]). A score ≥15 on questions 1-9 of the PHQ-9 corresponds to severe major depression.
    20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3.0 times the upper limit of normal at Screening Visit 1 (each confirmed by a repeat test) or any other laboratory abnormality that in the opinion of the Investigator would contraindicate study participation.
    21. Estimated Glomerular Filtration Rate (eGFR by Cockcroft-Gault formula) ≤30 mL/min estimated from serum creatinine, body weight, age and gender at Screening(Visit 1).
    22. Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change from Baseline in mean average daily pain over 7 days at Week 16 as measured by an 11-point Numeric Rating Scale (NRS).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The End of Trial is defined as the date the last patient completes the Week 24 or Early Termination visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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